-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, TPUEK1OV2l7HxwyJ/W9cpf5GCUUPJ62K1tADgw4mPeJxq64/o/7wUjnbXsk1rBia UX+3wGKAenqhxinFa01LKw== 0001157523-10-002691.txt : 20100504 0001157523-10-002691.hdr.sgml : 20100504 20100504074515 ACCESSION NUMBER: 0001157523-10-002691 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20100504 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100504 DATE AS OF CHANGE: 20100504 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NMT MEDICAL INC CENTRAL INDEX KEY: 0001017259 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 954090463 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21001 FILM NUMBER: 10794966 BUSINESS ADDRESS: STREET 1: 27 WORMWOOD STREET CITY: BOSTON STATE: MA ZIP: 02210 BUSINESS PHONE: 6177370930 MAIL ADDRESS: STREET 1: 27 WORMWOOD STREET CITY: BOSTON STATE: MA ZIP: 02210 FORMER COMPANY: FORMER CONFORMED NAME: NITINOL MEDICAL TECHNOLOGIES INC DATE OF NAME CHANGE: 19960619 8-K 1 a6274358.htm NMT MEDICAL, INC. 8-K


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549


FORM 8-K


CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 4, 2010


NMT Medical, Inc.
(Exact Name of Registrant as Specified in Charter)


Delaware

000-21001

95-4090463

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

 

(IRS Employer

Identification No.)

27 Wormwood Street
Boston, Massachusetts

 

02210-1625

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including area code: (617) 737-0930

Not Applicable
(Former Name or Former Address, if Changed Since Last Report)


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))



Item 2.02. Results of Operations and Financial Condition.

On May 4, 2010, NMT Medical, Inc. announced its financial results for the quarter ended March 31, 2010. The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Current Report on Form 8-K and the Exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.
  (d) Exhibits.

See Exhibit Index attached hereto.


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

NMT MEDICAL, INC.

 
Date: May 4, 2010 By:

/s/ Richard E. Davis

Richard E. Davis

Chief Operating Officer


Exhibit Index

Exhibit No.

 

Description

99.1

Press Release dated May 4, 2010.

EX-99.1 2 a6274358ex99_1.htm EXHIBIT 99.1

Exhibit 99.1

NMT Medical Announces First-Quarter 2010 Financial Results

CLOSURE I Data Analysis Commences on Schedule; Company on Track for Third-Quarter PMA Submission to the FDA

BOSTON--(BUSINESS WIRE)--May 4, 2010--NMT Medical, Inc. (NASDAQ: NMTI), an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures, today announced financial results for the quarter ended March 31, 2010.

First-Quarter Results

First-quarter 2010 total revenues were approximately $3.0 million compared with approximately $3.5 million for the quarter ended March 31, 2009.

Cardiac septal repair implant sales in North America for the first quarter of 2010 were approximately $2.0 million compared with approximately $2.3 million in the first quarter of 2009. Implant sales outside of North America were approximately $1.0 million in the first quarter of 2010 compared with $1.2 million in the corresponding period of 2009.

For the first quarter of 2010, NMT reported a net loss of approximately $7.9 million, or $0.54 per share, compared with a net loss of approximately $3.8 million, or $0.29 per share, for the corresponding period in 2009. The net loss for the first quarter of 2010 included a non-cash pre-tax expense of $4.7 million related to the change in fair value of the warrants issued in February 2010 as part of the Company’s $5.8 million financing. NMT reported a lower loss from operations of approximately $3.2 million, or $0.22 per share, in the first quarter of 2010 compared with $3.8 million, or $0.29 per share, in the same period of 2009.

Management Comments

“NMT’s total revenues for the first quarter of 2010 were in line with our expectations,” said President and Chief Executive Officer Frank Martin. “The ongoing general macroeconomic softness in North America and Europe continues to affect our implant sales. In addition, we believe the growing anticipation in the medical community for the results of CLOSURE I, our pivotal patent foramen ovale (PFO)/stroke and transient ischemic attack (TIA) trial in the United States may be slowing the referral pattern of patients for these procedures. Despite these short-term challenges, we are encouraged by the rate of acceptance of our technologies as we enter new international territories.”


“Data for CLOSURE I were recently locked and the analysis commenced on schedule,” Martin said. “By the fall of 2010, the trial will be complete and 100 percent of the randomized patient follow-up data will be available. Pending a positive outcome, we are continuing to target the third quarter of 2010 to submit an application for our STARFlex® device for the stroke and TIA indication to the U.S. Food and Drug Administration for Pre-Market Approval.”

Chief Operating Officer, Richard E. Davis, said, “We have taken important steps to strengthen our balance sheet. During the first quarter, we completed a $5.8 million financing through a private placement of common stock and warrants. Since June 2009, we also have an established credit facility to draw from, that allows us to borrow up to a maximum of $4 million, subject to borrowing availability. In addition, we recently filed a $30 million universal shelf registration statement that, if and when the registration statement is declared effective, will enable us to opportunistically raise additional funds, subject to market conditions, as needed.”

“Our current financial position gives us more confidence that we have the capital necessary to fully support our ongoing clinical trials and development programs and execute our business plan, including the commercial launch of STARFlex® for the stroke and TIA indication,” said Davis. “However, we are continuing to tightly manage expenses, preserve cash, and adjust our operating plan, as appropriate, with the goal of minimizing our operating loss and cash used in operating activities. As of March 31, 2010, cash, cash equivalents and marketable securities were approximately $10.7 million.”

“We will continue to identify new territories to establish distribution partnerships for our BioSTAR® technology as a cost-effective strategy to increase unit sales without incurring significant expenses. Pending results of the CLOSURE I trial, we continue to anticipate that full year 2010 revenues will increase modestly from 2009 levels,” concluded Davis.

Conference Call Reminder

Management will conduct a conference call at 9:30 a.m. ET today to review the Company’s financial results and provide a business update. Individuals who are interested in listening to the live webcast should log on to the “Investors” section of NMT Medical’s website at www.nmtmedical.com. The conference call also may be accessed by dialing (877) 407-5790 or (201) 689-8328. For interested individuals unable to join the live conference call, a replay will be archived for one year via webcast on the Company’s website.

About NMT Medical, Inc.

NMT Medical is an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures. NMT is currently investigating the potential connection between a common heart defect that allows a right-to-left shunt or flow of blood through a defect like a patent foramen ovale (PFO) and brain attacks such as embolic stroke, transient ischemic attacks (TIAs) and migraine headaches. A common right-to-left shunt can allow venous blood, unfiltered and unmanaged by the lungs, to enter the arterial circulation of the brain, possibly triggering a cerebral event or brain attack. More than 32,000 PFOs have been treated globally with NMT's minimally invasive, catheter-based implant technology.

Stroke is a leading cause of death in the United States and the leading cause of disability in adults. Each year, 750,000 Americans suffer a new or recurrent stroke and an additional 500,000 Americans experience a TIA.

For more information about NMT Medical, please visit www.nmtmedical.com.

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements – including statements regarding the timing, cost, clinical status, and outcome of the Company’s CLOSURE I trial, its ongoing clinical trials and development programs, the Company’s expected savings from cost reductions, the Company’s revenue expectations for 2010, the success of its new distribution partnerships, expansion of the Company’s cardiovascular business and market opportunities, including stroke, TIA and any other new applications for the Company’s technology or products, regulatory approvals for the Company’s products in the United States and abroad and the Company’s investment in product development – involve known and unknown risks, uncertainties or other factors that may cause actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that may cause such a difference include, but are not limited to, the Company’s ability to develop and commercialize new products, a potential delay in the regulatory process with the U.S. Food and Drug Administration and foreign regulatory agencies, as well as risk factors discussed under the heading “Risk Factors” included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2009 and subsequent filings with the U.S. Securities and Exchange Commission.


       
NMT Medical, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited)
 
For The Three Months Ended
March 31,
  2010       2009  
 
Product sales

$

2,994,308

$

3,477,771
 
Costs and expenses:
Cost of product sales 1,226,949 1,409,246
Research and development 1,824,006 2,194,235
General and administrative 1,955,644 2,402,527
Selling and marketing   1,189,681     1,300,459  
Total cost and expenses   6,196,280     7,306,467  
 
   
Loss from operations   (3,201,972 )   (3,828,697 )
 

Other (expense) income:

Loss on change in fair value of warrants (4,654,597 ) -
Currency transaction loss (50,569 ) (20,890 )
Interest income   1,679     56,652  
Total other (expense) income   (4,703,487 )   35,762  
 
Loss before income taxes (7,905,459 ) (3,792,935 )
 
Income tax expense   10,489     9,838  
 
Net loss $ (7,915,948 ) $ (3,802,773 )
 
 
Basic & diluted loss per common share: $ (0.54 ) $ (0.29 )
 
Basic & diluted weighted average common shares outstanding:   14,595,680     13,101,205  

   
NMT Medical, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
 
At March 31, At December 31,
  2010     2009  
 
Assets
Current assets:
Cash and cash equivalents $ 8,104,749 $ 8,926,329
Marketable securities 2,621,810 -
Accounts receivable, net 1,849,079 1,683,829
Inventories 1,871,649 1,658,646
Prepaid expenses and other current assets   1,046,148     1,029,348  
Total current assets 15,493,435 13,298,152
 
Property and equipment, net   642,189     694,520  
 
 
$ 16,135,624   $ 13,992,672  
 
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 4,881,406 $ 5,017,863
Accrued expenses   4,938,354     5,840,908  
Total current liabilities 9,819,760 10,858,771
 
Warrant liability 6,996,071 -
Other long-term liabilities   568,364     554,143  
Total long-term liabilities 7,564,435 554,143
 
Stockholders' equity:
Preferred stock, $.001 par value
Authorized--3,000,000 shares
Issued and outstanding--none - -
Common stock, $.001 par value
Authorized--30,000,000 shares
Issued and outstanding-- 16,058,319 and 13,268,294
shares in 2010 and 2009, respectively 16,058 13,268
Additional paid-in capital 57,261,150 53,175,464
Less treasury stock - 40,000 shares at cost (119,600 ) (119,600 )
Accumulated other comprehensive loss (857 ) -
Accumulated deficit   (58,405,322 )   (50,489,374 )
Total stockholders' equity   (1,248,571 )   2,579,758  
 
$ 16,135,624   $ 13,992,672  

CONTACT:
NMT Medical, Inc.
Richard E. Davis, 617-737-0930
Chief Operating Officer
red@nmtmedical.com

-----END PRIVACY-ENHANCED MESSAGE-----